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Intellectual Property: Is Life An Invention?

Suppose you'd just cracked the DNA code and you knew a good patent lawyer. Could you patent the code ... and would it be ethical? Probably neither, but you might be forgiven for thinking some of today's biotech companies and their intellectual property agents would patent your granny, given half the chance. No issue arouses more controversy in biotechnology than patenting.

For the past 10 years, the European biotechnology industry and environmental, patients', and religious groups have argued, lobbied, and countercampaigned over what became known as patenting life. The passing in 1998 of the European Union's (EU's) directive heavily in bioindustry's favor has done nothing to lessen what is, at heart, a profound moral conflict. Is it unethical to claim exclusive rights over the building blocks of life--to patent genes or the transgenic organisms that result from recombinant DNA technology?

Some patent lawyers say morals have nothing to do with it. For them patenting is just a technical legal procedure expressing a contract between an inventor and society, to publish the information in exchange for a limited period of exclusive rights for the inventor. Yet in that very assertion is a set of ethical values--of open access to information to benefit society, of rewarding inventiveness, and of basic justice to prevent someone selling your invention without due recompense. You cannot escape the moral dimension in patenting, or of science itself. To deny this is to claim that he activities of one special set of people are immune from society's wider values--a claim of exclusive powers that sits uneasily in a democracy. And once patenting involves living organisms and biological material, as the European Commission's bioethics advisers concluded, ethical issues become pivotal.

Patenting life is a misnomer. If anyone invented life, it was god, and theologians would say he gave it as a free gift to all and that, despite the alarming media inclination to genetic determinism, there is far more to life than the genetic code. But should anyone then claim bits of the coding as their exclusive intellectual property? The wider ethical answer is "no." It is part of the global commons, the genetic inheritance surely bequeathed to everyone, not just to opportunists. The commonsense answer is also "no." You are only supposed to be able to patent inventions, and no one has so far invented a gene; they are discoveries.

Not according to the EU patent directive. To have an excuse for patenting genes and not lose commercial advantage to the United States, it exploited the idea of "copy genes." Identifying a gene requires copying it via bacteria or chemicals. Because that's a technical process, it magically transforms the gene into something you invented. To the patent lawyers this is no different from artificially synthesizing a natural chemical product. To most ordinary people and also quite a lot of geneticists, it is a sleight of hand that is as illogical as it is unethical. Genes are more than mere chemicals. It's the information coded in the gene that is crucial, and by definition, that remains the same. Copying is also a standard procedure with no novelty. Patenting genes is illogical, unethical but legal. Patent law has found a way to turn discoveries, as most people would mean the term, into inventions, for commercial convenience.

The crucial question is what have you really invented? Not the gene, clearly. The inventiveness is in what you would use it for. The use of a newly identified human gene for producing a particular protein for a specific therapy would meet all the criteria for patenting and would not be unethical, as such. The problem is, as one biotech managing director said recently, "companies try it on." The pressure to capitalize on the invention for as much as you can get away with leads to wanting to patent the gene itself. The excuse given is that it is easier to defend a product patent--the gene--than the application. But is legal convenience reason enough to run roughshod over ethical values, for what is basically greed? It is also widely recognized that the broad patents that result from such logic have often shut down areas of potential development. Patents are not meant to prevent research, but in practice who would risk a multimillion-dollar research investment in an area already fenced off by broad patents? Research will flourish best when basic ethics is respected.

Much the same applies to transgenic animals. To claim you invented a whole mouse merely by adding three genes is absurd, but the original oncomouse claim was to patent the entire animal. What is the meaning of intellectual property rights regarding a creature that can get up and run away? The point is where to draw the line. To patent a novel gene construct used in this or that creature seems fair enough, as it is truly inventive. To patent a transgenic animal or plant, however, violates the normal distinction most world views and value systems draw between what is alive and what is not. The ethical stance of the EU patent directive is that this normal value distinction is irrelevant if you can intervene technically and can sell the resulting creature. For political convenience it made a few ad hoc distinctions about politically sensitive issues like cloning, but fundamentally its values are those of the commercial jungle.

As we are seeing over genetically modified food, a basic failure to consider the wider ethical context of such commercial ambitions is endangering the very future of European biotechnology. It also could affect the future of others. Acquiring genes abroad can abuse the rights and cultures of indigenous peoples, for whom intellectual property is meaningless and who have nothing comparable to barter in this alien currency. Many in medical research now fear that the infamous and discredited "no patents, no cure" lobbying slogan for patented genes may now mean therapies too expensive for the patients it was claimed to cure.

And where does the public have any say in all this? The refusal by the European Commission to allow the setting up of a special ethical committee to examine patent applications--in Commissioner Monti's words, to avoid "disturbing the patent process"--has horrified many as a statement that human social and ethical values are irrelevant compared to the prosperity of the biotechnology industry. This logic may instead prove its downfall. What started as a genuine question of justice has become winner takes all. If biotechnology is to have any social acceptance, it is time for it to moderate this trend before it is too late, and it starts with patents.